Outstanding Results From Major Ovarian Cancer Screening Trial Shows the High Performance of ROCA®, Paving the Way for Its Launch by Abcodia

Study shows that ROCA® detects 86% of women with ovarian cancer before there are any symptoms; twice as many than the use of a single assessment of CA125.

When ROCA® is used with an ultrasound scan as the follow up test, screening can rule out almost 100% of women who are cancer-free.

Based on these impressive data, Abcodia prepares to launch ROCA® into the private market in 2015.

Abcodia, a specialist company engaged in the development of tests for the early detection of cancer, is to make ROCA® available as an innovative ovarian cancer screening test this year, on the back of new clinical data further indicating its high performance.

ROCA® continues to be validated in a major ovarian cancer screening study (UKCTOCS) and a new publication reports that it detected twice as many malignancies than the traditional single assessment of CA125 level.

This latest study from University College London, published in the Journal of Clinical Oncology[1], highlights that the use of ROCA® accurately detected 86% of women with ovarian cancer and ruled out almost 100% of women who were cancer free. The test is twice as effective in identifying cancers than the traditional method of simply measuring CA-125 levels where clinicians consider values above 35 unit per ml to be worrisome. The study also reports that women with ovarian cancer who were detected through ROCA screening had levels that were below this clinically used cut-off, and 49% of such cases being stage I or II. Abcodia now awaits the complete survival and mortality results, expected to be available later in 2015.

Abcodia's initial plans are to make the ROCA® Test available to women through private gynaecologists in the UK from this summer and in the US later in 2015.

"These latest results are impressive and reaffirm the results from earlier UK and US studies," said Dr Julie Barnes, CEO of Abcodia, "They highlight the sophistication of ROCA® in being able to accurately distinguish between asymptomatic women with and without ovarian cancer, despite in many cases, their serum CA125 level appearing within the normal range."

"Given these latest results, it is important that as many women as possible are offered ovarian cancer screening with ROCA®, particularly women who are at risk, either because of their age (over 50) and post-menopausal status, or because they have a known family history of ovarian cancer or a BRCA gene mutation."

Professor Ian Jacobs, co-inventor of ROCA® and academic founder of Abcodia, said: "I am excited about the results of ROCA® as reported in this study. My hope is that the high sensitivity and specificity in detecting ovarian cancer earlier will be sufficient to save the lives of many women who are unfortunate enough to develop this disease."